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Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)

ConditionsSedationAnalgesia Assessment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-60
SponsorOman Medical Speciality Board

About this trial

To evaluate the depth of sedation, as well as onset, and recovery times, satisfaction of sedation , adverse events associated with Atomized Midazolam \& Fentanyl and Dexmedetomidine during procedural sedation in a diverse population spanning from 2 to 60 years old at these three prominent Omani healthcare facilities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 2 to 60 years.

Patients undergoing EM procedures requiring sedation.

Disqualifiers

Patients with contraindications to any of the sedation agents being studied.

Patients with a history of adverse reactions or allergies to the study medications.

Drug interactions: Patients taking certain medications that may interact adversely with the study medications.

Drug Abuser

Trial design

Design model

Parallel

Treatments tested in this trial

  • atomizer

    Device

    use atomizer to provide the medication in procedure sedation

  • rescue medication

    Drug

    will be used as rescue if the atomizer medication not fully sedated

  • Midazolam

    Drug

    Intranasal administration for procedural sedation.

  • fentanyl

    Drug

    Intranasal administration for procedural sedation.

  • Dexmedetomidine

    Drug

    Intranasal administration for procedural sedation.

  • Placabo

    Drug

    use atomizer to provide the placebo in procedure sedation

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: midazolame $ fentanylOther 4 interventions
Group B: dexetomidateOther 4 interventions

Trial outcomes

Primary outcomes

1

depth of sedtion

using MOAA/S score, Modified Observer's Assessment of Alertness/Sedation Scale , as 0 high score for deep sedation, 5 not in deep sedation

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Medical Speciality Board

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: